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Background & Aims: There are limited prospective data and long-term follow-up on cholangioscopy-directed management of difficult bile duct stones. The study objectives were to evaluate the safety and efficacy of cholangioscopy-directed lithotripsy in patients who had failed standard endoscopic retrograde cholangiopancreatography (ERCP) techniques and to determine the stone recurrence rate. Methods: Consecutive patients with biliary stones referred for cholangioscopy after failure of conventional stone therapy were enrolled and followed prospectively. Results: Between February 2000–October 2004, 32 consecutive patients had cholangioscopy-directed lithotripsy (30 electrohydraulic lithotripsy, 2 mechanical) after a mean of 3.3 (range, 2–14) failed ERCPs. Stones were intrahepatic (N = 8); extrahepatic (N = 18); or both (N = 6). Biliary strictures were present in 20 (63%) patients. Cholangioscopy identified additional stones not seen at ERCP in 9 (28%) patients. A mean of 1.4 lithotripsy sessions achieved complete (N = 26, 81%), partial (N = 5, 16%), or failed (N = 1, 3%) stone clearance. Follow-up was available in 28 (88%) patients for a mean of 29.2 months (95% confidence interval, 20.3–38.1 months). Stone recurrence occurred in 4 of 22 (18%) patients with complete clearance and follow-up data; 3 had primary sclerosing cholangitis. There were 2 minor periprocedural complications and 1 late complication. Conclusions: Cholangioscopy-directed lithotripsy is a safe and effective treatment in patients who have failed standard ERCP stone removal techniques. Stone recurrence is low in patients who had complete stone clearance except in patients with primary sclerosing cholangitis. Cholangioscopy detects stones missed by cholangiography.

449 Variation in Learning Curves and Competence for Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees (AETs) Using Cumlative Sum Analysis (CUSUM)Implication for American Scoiety for Gastrointestinal Endoscopy Society for Gastrointestinal Endoscopy Recommendations for Training Sachin Wani*, Andrew Y. Wang, Christopher J. Dimaio, V. Raman Muthusamy, Rajesh N. Keswani, Brian C. Brauer, Jeffrey J. Easler, Roy D. Yen, Ihab El Hajj, Norio Fukami, Kourosh F. Ghassemi, Susana Gonzalez, Lindsay Hosford, Thomas G. Hollander, Vladimir M. Kushnir, Jawad Ahmad, Faris Murad, Anoop Prabhu, Rabindra R. Watson, Daniel S. Strand, Stuart K. Amateau, Raj J. Shah, Steven A. Edmundowicz, Daniel Mullady University of Colorado, Centennial, CO; University of Virginia Health System, Charlottesville, VA; Icahn School of Medicine at Mount Sinai, New York, NY; Feinberg School of Medicine Northwestern University, Chicago, IL; Washington University School of Medicine, St. Louis, MO; University of California, Los Angeles, Los Angeles, CA Background: There are limited data on learning curves and competence in ERCP and the guidelines set forth by the ASGE are largely based on expert opinions and biliary cannulation rates (180 total procedures). These guidelines have not been validated, do not account for different rates of learning, and other relevant quality indicators in ERCP.AimTo prospectively define learning curves and measure competency among AETs at multiple training centers using a standardized data collection tool. Methods: AETs were supervised and graded at 5 training programs and introduced to all aspects of ERCP at the onset of training. Starting with 25 hands-on exam, each AET was graded on every ERCP exam during the 1-yr training period. A standardized ERCP competency assessment tool was used. Case number, indication and grade of difficulty were recorded. Technical and cognitive aspects assessed are shown in Table. A 4-point scoring system was used: 1-no assistance, 2-achieves with minimal verbal cues, 3-multiple verbal cues or hands on assistance, 4-unable to complete. CUSUM analysis was applied to produce learning curves for individual components of ERCP performance (success defined as score of 1). Acceptable and unacceptable failure rates of 10% (p0) and 20% (p1) respectively were used. Sensitivity analyses varying p1 between 0.2-0.35 and assessing competence using a less stringent definition of success (score of 1 or 2) were performed. Results: Five AETs were included with a total of 1047 graded ERCPs [mean 209.8 (SD 91.6)/AET]. Distribution of cases based on indication was: biliary 833 (80%), pancreatic (13%) and biliary and pancreatic 73 (7%). With regards to ASGE degree of difficult grade, the majority were biliary grade 1 (nZ591, 56.4%). There were overall 379 (38.9%) procedures in cases with a native papilla and sphincterotomy was performed in 474 (56.9%) cases. Overall mean time allowed for cannulation for AETs was 3.1 minutes (SD 3.6). Overall learning curves demonstrated substantial variability (Table). Nearly all AETs achieved competence in basic techniques, stent removal, overall cannulation, wire placement, balloon sweeps and cognitive aspects. However, none achieved competence in native papilla cannulation and sphincterotomy. Similarly, only 1-2 AETs achieved competence in stone clearance, dilation and insertion (Figure). Sensitivity analyses described above increased the proportion of AETs that achieved competency (Table). Conclusions: Results from this multicenter prospective study demonstrate substantial variability in achieving competency and there is a consistent need for more supervision especially for biliary cannulation and sphincterotomy than currently recommended in ASGE guidelines. Large multicenter study focusing on an assessment tool to accurately define trainee progression providing structured and objective feedback is currently underway. Table: Advanced endoscopy trainees achieving competence based on case number and sensitivity analyses* AB150 GASTROINTESTI Number of AETs achieving competence NAL ENDOSCOPY Procedure number at which competency was achieved Volume 81, Maximum number of AETs achieving competence based on sensitivity analyses* Basic technique Intubation 5 19, 21, 21, 21, 55 5 Achieving short position 5 19, 19, 26, 35

Background & Aims: Our aim was to assess the safety of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) in an ambulatory endoscopy center (AEC). Methods: Complications occurring in consecutive patients undergoing ERCP or EUS from March 2003 to February 2004 at our AEC were recorded prospectively. Comprehensive complications were defined as consensus criteria plus other adverse events: use of reversal agents, unplanned hospital admission, hospitalization beyond planned 23-hour observation, unplanned emergency department or primary care provider visit, and 30-day mortality. Results: A total of 497 patients (median age, 57 y; 82% American Society of Anesthesiologists class II or III) underwent 685 procedures. Monitored or general anesthesia was used in 25% of EUS and 50% of ERCP procedures. ERCP interventions were as follows: biliary or pancreatic stenting (N = 168), stone extraction (N = 70), sphincterotomy (N = 62), sphincter of Oddi manometry (N = 53), other (N = 66). EUS indications were as follows: known or suspected pancreatic mass (N = 103), upper-gastrointestinal mass/submucosal lesion (N = 71), luminal malignancy staging (N = 40), other (N = 96); 52% had EUS fine-needle aspiration. There was follow-up evaluation in 94% of the patients. There were 43 comprehensive ERCP complications (12.9%), 18 (5.4%) of these fit consensus criteria: pancreatitis (N = 14), cholangitis (N = 2), and perforation (N = 2). There were 9 comprehensive EUS complications (2.9%), 2 (.7%) of these fit consensus criteria: pancreatitis (N = 1) and bleeding (N = 1). Other adverse events for ERCP and EUS were as follows: prolongation of 23-hour observation (N = 14), emergency room visits (N = 3), primary care physician visits (N = 6), use of reversal agents (N = 3), unplanned admissions (N = 2), infection (N = 3), and death (N = 1). Conclusions: ERCP and EUS can be performed in an AEC, provided mechanisms for admission and anesthesia support are in place. The assessment of comprehensive complications is more reflective of adverse events related to ERCP and EUS than consensus criteria alone.

Symptomatic cholelithiasis is a common disease in the general population with an increased prevalence in patients with cirrhosis. While cholecystectomy is the procedure of choice for the treatment of symptomatic cholelithiasis, cirrhotics have an increased risk of complications associated with this therapy. We have found that placement of an endoscopic gallbladder stent is an alternative, less invasive treatment for cirrhotic patients with symptomatic gallbladder disease and describe our experience here.A retrospective medical record review of 23 patients with cirrhosis who underwent endoscopic retrograde cholangiography with gallbladder stent placement for symptomatic gallbladder disease from July 1994 to August 2004.Indications for stent placement included recurrent biliary colic (56.5%), acute calculous cholecystitis (39%), acalculous cholecystitis (8.6%), and gallstone pancreatitis (8.6%). All patients experienced resolution of their symptoms following stent placement. Twenty patients (87%) were asymptomatic from 5 days to 3 years post-procedure until transplantation, death, or end of study period. Nine patients (39%) underwent liver transplantation, 5 days to 34 months after the procedure. Eleven patients are well, with ten patients awaiting liver transplantation. Three patients developed late complications and were treated successfully with antibiotics.Endoscopic stenting of the gallbladder may be a potential treatment for symptomatic gallbladder disease in patients with cirrhosis awaiting liver transplantation, considered to be high-risk for cholecystectomy.

Objectives Assess the role of cholangioscopy in primary sclerosing cholangitis for 1) detection of cholangiocarcinoma using cholangioscopy-assisted biopsy 2) detection of stones not seen on cholangiography 3) stone removal with cholangioscopy-directed lithotripsy. Methods Prospective cohort of consecutive patients referred for cholangioscopy to evaluate dominant strictures or stones. A data collection sheet was employed. Follow-up was by chart review/phone contact. Clinical improvement was defined as resolution of jaundice or > or =50% reduction in pain or cholangitis episodes requiring hospitalization. Results 41 patients (30M, 11F) had 60 cholangioscopy procedures (55 per oral, 5 percutaneous). 33/41 (80%) patients underwent 44 tissue sampling events. Histology positive for extrahepatic cholangiocarcinoma (N = 1), negative/atypical (N = 31), and inadequate (N = 1). Stones were found in 23/41 (56%) patients, of which 7/23 (30%) were missed on cholangiography and detected only by cholangioscopy. 9/23 (39%) underwent cholangioscopy-directed lithotripsy. Stone clearance: complete (N = 10, 7 by cholangioscopy-directed lithotripsy after failed conventional stone extraction); partial (N = 7); and not attempted (N = 6). Median follow-up was 17.0 months (range 1-56). Clinical improvement was achieved in 25/40 (63%). Eight patients have undergone transplant and cholangiocarcinoma was present in the explant of two at 1 and 12 months post-cholangioscopy, respectively. Conclusions This is the first series of patients with primary sclerosing cholangitis undergoing cholangioscopy for the evaluation of dominant strictures and cholangioscopy-directed stone therapy with demonstrable clinical benefits. Stones detected by cholangioscopy were missed by cholangiography in nearly one of three patients. Cholangioscopy-directed lithotripsy may be superior to conventional ERCP for achieving complete stone clearance. Despite the use of cholangioscopy, diagnosis of cholangiocarcinoma remains technically challenging.

Background Single-step EUS-guided transmural drainage of pseudocysts has been reported, but there are no published prospective studies on clinical outcomes. Objective To assess the safety and the efficacy of single-step EUS-guided placement of large endoprostheses to treat simple and complicated pseudocysts. Design Prospective cohort study. Setting Single tertiary referral center. Patients Consecutive patients referred for management of symptomatic chronic pancreatic pseudocysts >4 cm in size. Interventions Single-step EUS-guided transmural pseudocyst drainage performed with a linear-array echoendoscope for placement of 10F stents in adults and 7F stents in children. Main Outcome Measures Complete or partial (>50% reduction) resolution of pseudocyst on follow-up imaging, recurrence, clinical response, and procedure-related complications. Recurrence was defined as the reappearance of a pancreatic pseudocyst in the same location. Results There were 33 patients, with a mean age of 43 years. Median pseudocyst size was 8.5 cm (range, 4-20 cm). Fourteen patients (42%) had infected pseudocysts, 8 patients (24%) had gastric varices, and 16 patients (48%) had no visible endoscopic bulge. Stent placement was successful in 31 patients (94%). Twenty-seven patients (82%) had complete resolution of a pseudocyst; 4 patients (12%) had partial resolution, with symptom relief. There were 2 major complications and 3 minor complications. Recurrence of a pseudocyst was observed in only 1 patient over a median follow-up of 46 weeks. Limitations No randomized treatment arm comparing this technique with conventional endoscopic drainage. Conclusions Single-step EUS-guided transmural drainage with large endoprostheses is a safe and effective therapy for patients with simple and complicated pancreatic pseudocysts.

The principal extrarenal manifestation of autosomal dominant polycystic kidney disease (ADPKD) involves formation of liver cysts derived from intrahepatic bile ducts. Autocrine and paracrine factors secreted into the cyst would be positioned to modulate the rate of hepatic cyst growth. The aim of this study was to identify potential growth factors present in human ADPKD liver cyst fluid. Cytokine array and enzyme-linked immunosorbent assay analysis of human ADPKD liver cyst fluid detected epithelial neutrophil attractant 78, interleukin (IL)-6 (503 ± 121 pg/mL); and IL-8 (4,488 ± 355 pg/mL); and elevated levels of vascular endothelial growth factor compared with non-ADPKD bile (849 ± 144 pg/mL vs. 270 pg/mL maximum concentration). ADPKD liver cyst cell cultures also released IL-8 and vascular endothelial growth factor, suggesting that cystic epithelial cells themselves are capable of secreting these factors. Western blotting of cultured cyst cells and immunostaining of intact cysts demonstrate that cysteine-X-cysteine receptor 2, an epithelial neutrophil attractant 78 and IL-8 receptor, is expressed at the apical domain of cyst lining epithelial cells. Suggesting the cystic epithelial cells may exist in hypoxic conditions, electron microscopy of the ADPKD liver cyst epithelium revealed morphological features similar to those observed in ischemic bile ducts. These features include elongation, altered structure, and diminished abundance of apical microvilli. In conclusion, IL-8, epithelial neutrophil attractant 78, IL-6, and vascular endothelial growth factor may serve as autocrine and paracrine factors to direct errant growth of ADPKD liver cyst epithelia. Interruption of these signaling pathways may provide therapeutic targets for inhibiting liver cyst expansion. (Hepatology 2004;40:836–846).

Review of ERCP x-ray films by radiologists is routine, but the utility of this practice is unproven. The aim of this study was to assess whether the routine post-procedural interpretation of ERCP films by radiologists alters patient management.A retrospective analysis of 212 ERCPs followed by a prospective analysis of 112 ERCPs was performed. Comparative ductogram interpretations were categorized as: I, complete agreement; II, minor findings reported only by the radiologist; III, findings reported only by the endoscopist; and IV, major findings reported only by the radiologist that altered or should have altered management.In the retrospective analysis, 289 ductograms were identified, and interpretations were classified as: category I, 73%; category II, 16%; category III, 10.7%; and category IV, 0.3%. In the prospective study, interpretations of 167 ductograms were analyzed and classified as follows: category I, 84%; category II, 11%; category III, 5%; category IV, none.Post-procedure interpretation of ERCP spot x-ray films by radiologists adds little to patient management. Selective consultation with radiologists would appear to be more appropriate than review by radiologists of ERCP spot x-ray films on a routine basis.

Background: The industry standard since 1990 for self-expanding biliary metallic stents has been the Wallstent. In 1998 the Spiral Z-stent was released. This randomized trial compared the Z-stent with the Wallstent in the treatment of malignant biliary obstruction. Methods: Patients with unresectable malignant biliary obstruction distal to the bile duct bifurcation were randomized to receive a 10-mm diameter Wallstent or a 10-mm diameter Z-stent. Results: A total of 145 patients were randomized; 13 were excluded. Sixty-four patients who received a Z-stent and 68 who had a Wallstent are included in the analysis. Tumors responsible for bile duct obstruction were pancreatic cancer (108), cholangiocarcinoma (15), metastatic cancer (6), and papillary cancer (3). Metallic stents were successfully placed in all patients. Seven technical problems were encountered during placement of the Z-stent and 5 with the Wallstent. There were 21 occlusions requiring reintervention (8 Z-stent, 13 Wallstent; p = 0.30). Median time to reintervention was the following: Z-stent, 162 days; Wallstent, 150 days (p = 0.22). A total of 104 patients died of progressive disease or other cause; 7 patients remain alive with patent stents. The overall calculated median patency rates were: Z-stent, 152 days; Wallstent, 154 days (p = 0.90). Conclusions: The Spiral Z-stent is comparable with the Wallstent in terms of placement, occlusion rates, and overall patency. Occasional early occlusion of both stents suggests tumor characteristics instead of the size of the mesh openings in the stents as important factors. (Gastrointest Endosc 2003;57:830-6.)

Introduction: The nature of pancreatic cysts often remains uncertain, despite several tests, resulting in unoptimal management for patients. nCLE is an imaging technique, enabling microscopic observation of solid organs, in vivo and in real-time, during an EUS-FNA procedure. This technique could potentially provide useful information to establish a differential diagnosis between mucinous and non mucinous neoplasms. A recent study, INSPECT, described nCLE criteria for the characterization of intraductal papillary mucinous neoplasms (IPMN). Further descriptions were needed to identify nCLE criteria for the characterization of mucinous cystadenomas neoplasms (MCN) and non mucinous lesions. A prospective multicenter French study (CONTACT) aims at assessing the yield of nCLE for the diagnosis of pancreatic cystic tumors. Interim results presented criteria specific of serous cystadenomas (SCA). However, nCLE criteria for the characterization of MCN are still unknown. Materials and methods: Over 10 months, 31 patients without chronic pancreatitis and with a lonely pancreatic cyst > 2 cm large were enrolled. Following EUS examination, the AQ-Flex 19 miniprobe was introduced in a 19G needle and real-time video sequences of the cyst wall were recorded. Intracystic fluid obtained was analyzed. Final diagnosis of MCN (n=6) was based on surgery. The other lesions were considered as IPMN (n=5), pseudocysts (n=7) and SCA (n=13) on pathological consideration or expert consensus. Four gastroenterologists and two pathologists, unblinded to the final diagnosis studied the 31 nCLE videos records and compared their findings to the pathological specimen. Results: A particular pattern was furtively and recurrently seen in sequences acquired in three of the MCN lesions: an epithelial border lined the cyst wall, with or without deep blood vessels, and without papillary organization. These features were only observed in MCN sequences. These criteria correlate with the histological structure of those tumors that are characterized by a tall columnar mucin-producing epithelium underlined by a thick fibrous tissue with pseudo-ovarian stroma and vessels. Conclusions: The mucinous columnar epithelial border of MCN can be highlighted by nCLE. The validation of this criterion by an external group is undergoing and results will be available by the beginning of 2014. If proven to be accurate, this new sign might be useful for the diagnosis of mucinous cystadenoma neoplasms.

had familiar history ofIBD.Among the 93 IBD pts with arthralgias, rheumatologic assessment diagnosed rheumatologic diseases in 33 (88%) UC and in 44 (80%) CD pts. In particular, a diagnosis of SpAewas made in 50 (54%) IBD pts(54% peripheral SpA, 24%, axial SpA, 22% both), 24 (26%)Osteoarthritis, 6 (7%)Fybromialgia,3 (3%), Gout, 3 (3%)Rheumatoid Arthritis, 2 (2%) Psoriatic Arthritis, while diagnosis was inconclusive in 5 (6%) pts. After rheumatological assessment, a higher percentage of IBD pts were treated with diseasemodifying anti-rheumatic drugs (including anti-TNFs)(5.3% vs 15%, p=0.03, RR 1.6)and/ or with anti-COX2 (6.4% vs 27%; p